TEST

SPECIFICTIONS

Description

A white or almost white powder

Identification

According to the requirements

Specific rotation

+19°~ +26°

Loss on drying

≤1.0%

Residue on ignition

≤0.5%

15-epimer

≤0.5%

5,6-trans isomer

≤1.0%

Other max single impurity

≤1.0%

Total impurities

≤2.5%

  Residue solvents

Ethyl alcohol≤0.5%

Methanol≤0.3%

Acetonitrile≤0.041%

Tetrahydrofuran≤0.072%

Ethyl acetate≤0.5%

Dichloromethane≤0.06%

Assay(HPLC)

95.0~105.0%

Conclusion:

Complies with USP standards